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# denotes number symbol Note: dies comply with Marburg Medium cell dimensions:

Leaflet section:

(IN-OUT) page shows the leaflet section of the label-leaflet. The leaflet is a double sided strip of paper that is folded into 6 panels. It is not possible to show all 6 panels side-by-side in the A3 document, so each panel has been given a number and the diagram below shows the order of the panels as they will appear in the printed leaflet.

The leaflet section is glued to the carrier label at the leftside edge of the title panel.

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Title Panel

PACKAGE LEAFLET: INFORMATION FOR THE USER

Lactulose 3.3g/5ml Oral Solution {Active substance: Lactulose}

Read all of this leaflet carefully before you start using this

riedicine.

Keep this leaflet. You may need to read it again.

- If you have any further questions, ask your doctor or pharmacist.

- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Lactulose Solution is and what it is used for

2.    Before you take Lactulose Solution

3.    How to take Lactulose Solution

4.    Possible side effects

5.    How to store Lactulose Solution

6.    Further information

1. WHAT LACTULOSE SOLUTION IS AND WHAT IT IS USED FOR

Lactulose Solution belongs to a group of medicines called laxatives. It is used in the treatment of:

Chronic (long term) constipation: Constipation is a common complaint often due to not enough roughage or fibre in the diet, dehydration, immobility, illness or stress. Sometimes constipation may be due to more serious reasons. You should consult with your doctor if you suffer from constipation for a period of greater than 4 weeks.

Lactulose can help your bowels to move, and pass a stool if you are constipated. Lactulose does not enter the bloodstream. It acts by drawing water into the bowel and so softening the stool or motion. In this way Lactulose can encourage a normal bowel motion. Chronic portal systemic encephalopathy (hepatic coma): This is an uncommon condition where substances such as ammonia go into the blood stream. It can sometimes occur in patients with severe liver disease. Your doctor may prescribe Lactulose for you if you suffer from liver disease and he believes that you may develop or have developed hepatic encephalopathy.

Lactulose is broken down by the normal bacteria (germs) in the bowel to form acid which stops the formation and absorption of ammonia from the bowel into the blood stream. In this way it helps to treat hepatic encephalopathy.

2. BEFORE YOU TAKE LACTULOSE SOLUTION Do not take Lactulose Solution if:

-    you know that you are allergic (causing itching, reddening of the skin or difficulty in breathing) to Lactulose Solution or any of the other ingredients of Lactulose Solution listed at the end of this leaflet;

-    you are suffering from a blockage in your gut or intestine;

-    you suffer from a rare inherited condition of the metabolism called galactosaemia (an increase in a sugar called galactose in the blood).

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines that you have obtained without a prescription.

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Taking Lactulose Solution with food and drink: Lactulose Solution may be taken with a drink such as water or fruit juice. Pregnancy and breast-feeding

It is always best to avoid the use of medicines during pregnancy if possible. However, it is safe to take Lactulose Solution during pregnancy and when breast-feeding, as long as you follow the dosage recommendations.

Driving and using machines

There should be no problems when taking Lactulose Solution. Important information about some of the ingredients of Lactulose Solution: Lactulose Solution contains Lactose and Galactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicine.

3. HOWTO TAKE LACTULOSE SOLUTION

Lactulose Solution is for oral use only

The effects of Lactulose may not be seen for up to 48 hours,

therefore it is important to continue taking your medicine

regularly.

To treat constipation:

The table below gives the starting doses of Lactulose Solution depending on your age. However, the dose may be adjusted by your doctor depending on your needs to have the desired effect. Starting dose

Adults    15ml twice daily (3 x 5ml spoonful)

Children 5 to 10 years 10ml twice daily (2 x 5ml spoonful) Children under 5 years 5ml twice daily (1x 5ml spoonful)

Babies under 1 year 2.5ml twice daily (/ x 5ml spoonful)

(Dosage continued) To treat hepatic encephalopathy:

Higher doses of Lactulose Solution are required.

Starting dose

Adults 30-50ml three times daily (6-10 x 5ml spoonful) Elderly as above

Children not to be taken (lactulose is not suitable for children with this condition)

Your doctor may adjust your dose until two or three soft stools are produced a day.

If you take more Lactulose Solution than you should

Contact your nearest casualty department or tell your doctor or pharmacist straight away. Take this leaflet and any remaining solution with you so that the medical staff know exactly what you have taken.

If you forget to take Lactulose Solution

If you forget to take a dose of Lactulose Solution, take it as soon as you remember. If it is almost time for your next dose though do not double the dose - just carry on as before.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Lactulose Solution can cause side effects, although not everybody gets them. If any of these side effects become troublesome, stop taking the medicine and see your doctor as soon as possible.

The most common side effects probably affecting up to 1 in 10 people are: bloated stomach, excess wind or stomach cramps. You may suffer from these in the first few days of taking your medicine. These usually go away on continuation of your treatment.

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